Skip to main content
OpenTrials
Completed

NCT Number: NCT02045602

Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability of VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Locally Advanced Solid Tumors Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Metastatic Solid Tumors Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Vall d'Hebron, Barcelona, Spain

Loading trial locations.

About this study

The study consists of three parts:

  • Part I is a dose escalation study to determine the safety and tolerability of a single intravenous injection of VCN-01 alone
  • In Part II the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine.
  • In Part III the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine in a "delayed" schedule compared with Part II.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male/Female patients aged 18 years or over
  • Patients must provide written informed consent
  • Part I: Patients with histologically confirmed, locally advanced or metastatic solid tumors. Part II and Part III: Patients with histologically confirmed, pancreatic adenocarcinoma for which the established therapy is Abraxane®/Gemcitabine (clinical standard of care)
  • Life expectancy above 3 months
  • Patients willing to comply with treatment follow-up
  • ECOG Performance status 0 or 1
  • Adequate baseline organ function (hematologic, liver, renal and nutritional)
  • Use a reliable method of contraception in fertile men and women

Exclusion criteria

  • Active infection or other serious illness or autoimmune disease
  • Treatment with live attenuated vaccines in the last three weeks
  • Known chronic liver disease (liver cirrhosis, chronic hepatitis)
  • Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion
  • Viral syndrome diagnosed during the two weeks before inclusion
  • Chronic immunosuppressive therapy
  • Concurrent malignant hematologic or solid disease
  • Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.
  • Patients receiving full-dose anticoagulant / antiplatelet therapy
  • Adequate levels of neutralizing antibodies against adenovirus
  • Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency

Treatment and study plan

VCN-01

Genetic

Genetically modified human adenovirus encoding human PH20 hyaluronidase

Gemcitabine

Drug

1000 mg/m2 intravenous administration

Abraxane®

Drug

125 mg/m2 intravenous administration

Primary outcomes

  1. Safety and Tolerability by means of Adverse Events (AEs) and laboratory data

    Time frame: At least 6 months

  2. Recommended Phase 2 Dose (RP2D) by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities

    Time frame: At least 6 months

Secondary outcomes

  1. Presence of VCN-01 in tumor

    Time frame: Day 8-10

    Determination of VCN-01 by analyzing viral genome copies in tumor biopsy

  2. Viral Pharmacokinetics

    Time frame: Up to 48 h

    Determination of VCN-01 half-life by analyzing viral genome copies in blood

  3. Viral Shedding

    Time frame: Up to day 28

    And at least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)

  4. Neutralizing antibodies anti-VCN-01

    Time frame: 30 days after end of treatment phase

    At least up to 6 months follow-up in patients at the MTD

  5. Preliminary anti-tumor activity by Overall Response Rate (ORR)

    Time frame: CT or MRI scans every 8 weeks until disease progression

  6. Preliminary anti-tumor activity by Progression Free Survival (PFS)

    Time frame: CT or MRI scans every 8 weeks until disease progression

Sponsors and collaborators

Lead sponsor

Theriva Biologics SL

Industry

Registry information

Official study title

A Phase I, Multicenter, Open-label, Dose Escalation Study of Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Jan 27, 2014
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.